FDA approves first generic version of EpiPen: 5 things to know

After a yearslong delay, the FDA approved the first generic competitor to Mylan's EpiPen Aug. 16.

Here are five things to know:

1. Teva Pharmaceuticals, the largest generic drugmaker in the U.S., received FDA approval for its generic versions of both EpiPen and EpiPen Jr. Teva's initial application for its generic version of EpiPen was rejected by the FDA in 2016.

2. The products are auto-injectors for the emergency treatment of allergic reactions, including those that are life-threatening. The approval will bring competition to Mylan's EpiPen, which has drawn public criticism over its cost.

3. In 2016, Mylan introduced its own generic version of EpiPen after a public outcry over the branded version's price, which jumped more than 450 percent since 2004. The generic version costs $300 for a two pack, compared to the brand-name version which costs more than $600.

4. The approval comes at an optimal time. During the back-to-school push, sales of EpiPen spike as parents stock up for school. In recent months, patients and pharmacists in 45 states reported difficulty finding EpiPens, leading the FDA to issue a supply shortage alert.

5. This approval means patients living with severe allergies who require constant access to life-saving epinephrine should have a lower-cost option, as well as another approved product to help protect against potential drug shortages," said FDA Commissioner Scott Gottlieb.

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